Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05276908

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ultrasound-guided thoracolumbar interfascial plane block (TLIP)was first described in 2015 by Hand et al which also target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature(between the multifidus muscle (MF) and the longissimus muscle (LG)). The block was performed bilaterally at the level of L3 and they reported a reproducible area of anesthesia to pinprick in a mean (SD) area covering 137.4 (71.0) cm2 of the lower back (including the midline) after 20 minutes of the block. This procedure has subsequently been modified by Ueshima H et al in 2016 by targeting the injection in the plane between the longissimus and iliocostalis muscles (mTLIP) which helps avoiding the spread of local anesthetics to the ventral ramus and neuraxial space, thus, the modified TLIP block is considered to be a more refined version of the original TLIP block and safer and easier to perform.

There are limited number of studies investigating the analgesic efficacy of mTLIP block however, no previous study has demonstrated the ideal local anesthetic volume for this block in lumber spine surgery. Moreover, this technique is considered new regional anesthetic techniques and so both of them should be involved in further studies, on the other hand the comparison between both of them at the same study wasn't discussed before, and so we will proceed at this study.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Thoracolumbar interfascial plane block (TLIP)Technique Procedure: Anesthetic Management Drug: Bupivacaine Injection 10ml Drug: Bupivacaine Injection 20ml	N/A

Detailed Description

The aim of this study is to compare the post-operative analgesic efficacy of two different volumes of local anesthetics in bilateral modified thoracolumbar interfascial plane block in lumbar spine surgeries.

Prospective randomized double blinded study The study will be conducted in Kasr Alainy hospital orthopedic surgical theater. Adult patients undergoing lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae (eg. laminectomy, discectomy …). at Kasr Alainy hospital.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Analgesic Efficacy of Two Different Volumes of Local Anesthetics in Ultrasound-guided Modified Approach of Thoracolumbar Block in Patients Undergoing Lumbar Spine Surgeries; a Randomized Controlled Trial.

Actual Study Start Date :

Mar 3, 2022

Anticipated Primary Completion Date :

May 3, 2022

Anticipated Study Completion Date :

Jun 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mTLIP10 patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).	Procedure: Thoracolumbar interfascial plane block (TLIP)Technique A curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side. Procedure: Anesthetic Management Induction: Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium. Maintenance: Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position. Drug: Bupivacaine Injection 10ml patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
Experimental: mTLIP20 patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).	Procedure: Thoracolumbar interfascial plane block (TLIP)Technique A curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side. Procedure: Anesthetic Management Induction: Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium. Maintenance: Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position. Drug: Bupivacaine Injection 20ml patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).

Arm

Intervention/Treatment

Experimental: mTLIP10

patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).

Procedure: Thoracolumbar interfascial plane block (TLIP)Technique

A curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side.

Procedure: Anesthetic Management

Induction: Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium. Maintenance: Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position.

Drug: Bupivacaine Injection 10ml

patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).

Experimental: mTLIP20

patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).

Procedure: Thoracolumbar interfascial plane block (TLIP)Technique

Procedure: Anesthetic Management

Drug: Bupivacaine Injection 20ml

patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).

Outcome Measures

Primary Outcome Measures

Time to first rescue analgesia [24 hours]
measured from time of block administration to time of rescue analgesia administration

Secondary Outcome Measures

Total morphine consumption [24 hours]
Numeric Pain Rating Scale [24 hours]
Pain scale of managmet when zero indicates no pain and ten indicates maximum pain both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24postoperatively.
Modified Bromage score [2hours postoperative]
Modified Bromage score from 1 to 6: 1: Complete block (unable to move feet or knees). 2: Almost complete block (able to move feet only). 3: Partial block (just able to move knees). 4: Detectable weakness of hip flexion while supine (full flexion of knees). 5: No detectable weakness of hip flexion while supine. 6: Able to perform partial knee bend.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

● Both gender
Type of surgery: lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae
Physical status ASA I, II.
Age 18 to 65 Years.
Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion Criteria:

● Patients on preoperative opioid regimen for more than 1 month.
Patients with history of previous surgical operations in the lumbar region.
Patients with spinal deformities (eg. Scoliosis…..).
Hypersensitivity to Bupivacaine.
Extensive Lumbar spine surgeries like large tumor excisions, scoliosis correction or more than 2 level spine fixations.
Patients with communication difficulties.
Lumbar spine operations that will be performed with the patient in any position other than the prone position.
Severe neurological compromise (severe muscle weakness such as foot drop or sphincter disorders such as urinary incontinence).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Bassant Abdelhamid, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Bassant M. Abdelhamid, Assissnt professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05276908

Other Study ID Numbers:

MD-307-2020

First Posted:

Mar 14, 2022

Last Update Posted:

Mar 14, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Anesthetics

Study Results

No Results Posted as of Mar 14, 2022